DENTSPLY/International DENTSPLY/Caulk Safety Data Sheet …€¦ · Safety Data Sheet 530699 1. Identification Product Name Esthet•X® HD SDS Code Number 530699 Substance Identity

DENTSPLY/International

DENTSPLY/Caulk

Safety Data Sheet 530699

1. Identification Product Name Esthet•X

® HD

SDS Code Number 530699

Substance Identity

Esthet•X® HD High Definition Micro Matrix Restorative

Date of Last Revision 05/16/13

Manufacturer:

DENTSPLY Caulk

Address

38 West Clarke Avenue

Milford DE 19963-1805

http://www.caulk.com http://www.dentsply.com

Grades or Minor Variant Identities

Not Applicable

Information Telephone Number

(302) 422-4511 (8:00 AM – 4:30 PM Eastern Time)

Product Use (for Canada)

Light Curing Composite/Dental Filling Material Emergency Telephone Number


2. Hazard(s) Identification

Wash hands thoroughly after handling.

Wear protective gloves.

IF ON SKIN: Wash with plenty of soap and water.

If skin irritation occurs: Get Medical Advice/attention.

Take off contaminated clothing and wash before reuse.

3. Composition/Information on Ingredients Hazardous Components C.A.S. Number Exposure Limits %

Hydrophobic Amorphous Fumed Silica 68611-44-9 10 mg/m3 < than 5

Silica (Amorphous) 67762-90-7 3 mg/m3 < than 5

Barium boron fluoro alumino silicate glass 65997-18-4 10 mg/m3 < than 30

Barium boron alumino silicate glass 65997-17-3 10 mg/m3 < than 50

Urethane modified Bis-GMA dimethacrylate 126646-17-1 Not Established < than 10

Polymerizable dimethacrylate resins 24448-20-2/109-16-0 Not Established < than 20

Other Information: Colorants are inorganic iron oxides and titanium dioxide.

4. First Aid Measures Routes of Exposure First Aid Instructions Immediate Medical Attention Delayed Effects

Eye Rinse opened eye for several minutes under running water. If symptoms persist consult physician

Not Applicable Not Applicable

Skin Immediately wash with soap and water and rinse thoroughly Not Applicable Not Applicable

Inhalation Not Applicable Not Applicable Not Applicable

Ingestion Not Applicable Not Applicable Not Applicable

Mucosa Rinse tissue for several minutes under running water. If symptoms persist consult physician


Note to Physicians (Treating, Testing and Monitoring): Treat symptomatically.

5. Fire Fighting Measures Flame Propagation or Burning Rate

(for Solids) Not Applicable

Properties Contributing to Fire Intensity Not Applicable

Flammability Classification: Not Applicable Other: Not Applicable

Extinguishing Media: CO2, extinguishing powder, foam carbon dioxide or water

spray. Fight larger fires with water spray or alcohol resistant foam. Extinguishing Media to Avoid: Water with full jet.

Protection and Procedures for Firefighters: Firefighters should wear self-contained respiratory protective devices. Unusual Fire and Explosion Hazards: Formation of toxic, irritating gases is possible from the decomposition of the dimethacrylate resins. Product does not present an explosion hazard.

WARNING

CAUSES SKIN IRRITATION

6. Accidental Release Measures Containment Techniques: Material is a paste and as such will not flow. Spill/Leak Clean-up Procedures and Equipment: Wear protective clothing and scoop up bulk material and place in a labeled plastic or metal container.

Avoid gross skin contact to minimize the possibility of contact dermatitis to susceptible persons. Ensure adequate ventilation.

Evacuation Procedures: Not Applicable Special Instructions: Not Applicable Reporting Requirements: Not Applicable

7. Handling and Storage Handling Practices and Warnings: Product is intended for dental use only. Handling of this product should be by trained dental healthcare professionals only.

Observe normal care for working with chemicals. Storage Practices and Warnings: Store only in the original package. Keep package tightly sealed. Store in a dry area. Protect from exposure to direct light. Store away from food and beverages.

8. Exposure Control / Personal Protection

Occupational Exposure Limits: Not Applicable

Engineering Controls: Not Applicable

Individual Protection

Measures Personal Protective Equipment for Normal Use Personal Protective Equipment for Emergencies

Eye/Face Safety Glasses Not Applicable

Skin The glove material has to be impermeable and resistant

to the product.

Not Applicable

Inhalation Not Required Not Applicable

Body Protection Protective work clothing Not Applicable

9. Physical and Chemical Characteristics Appearance: Various shades of viscous paste. Odor: Characteristic sweet acrylic ester odor. Normal Physical State: Very High Viscosity Liquid (Paste) Melting Point: Not Applicable

Specific Gravity: 2.1 g/cm3 Solubility in Water: Not soluble pH: Not Applicable

Vapor Pressure (mm Hg): Not Applicable Vapor Density (AIR=1): Not Applicable Evaporation Rate (Butyl Acetate =1): Not Applicable

Flashpoint Method: Not Applicable Flammable (Explosive) Limits in Air LEL: Not Applicable UEL: Not Applicable

Autoignition Temperature: Not Applicable, Product will not autoignite.

Other: Not Applicable

10. Stability and Reactivity Data Incompatibility (Materials to Avoid): Strong Oxidizing materials.

Hazardous Products Produced During Decomposition: No dangerous decomposition products known if used according to Directions for Use.

Hazardous Polymerization: May Occur May Not Occur Conditions to Avoid: None known

Stability? Stable Unstable Conditions to Avoid: None known

11.Toxicological Information Toxicity Data, Epidemiology Studies, Carcinogenicity, Neurological Effects, Genetic Effects, Reproductive Effects, or Structure Activity Data:

Product is an irritant to the skin and mucous membranes. The unpolymerized product may be an irritant to the skin in susceptible persons. On the eye the product has an irritating effect. Sensitization: Repeated or prolonged contact with the unpolymerized material may cause sensitization for persons allergic to

acrylates and methacrylates. This product shows the following dangers according to internally approved calculation methods for composite materials: Irritant.

Emergency Overview Material is irritating to eyes, respiratory system and skin.

Routes of Exposure

Signs and Symptoms

Single, Repeated, or Lifetime Exposure

Severity (Mild, Moderate, Severe)

Acute and Chronic Health Effect(s) Target Organ(s)

Eye Material can cause

irritation.

Single Moderate Irritation and possible corneal damage Not Applicable

Skin Material may be an irritant

Single & Repeated Moderate Irritation or possible allergic response. Severe allergic response may result in

breathing difficulties.

Not Applicable

Inhalation Not Applicable Not Applicable Not Applicable Not Applicable Not Applicable

Ingestion Material is not harmful if swallowed using clinically

relevant quantities

Not Applicable Mild Not Applicable Not Applicable

Mucosa Material can cause irritation.

Single Mild Inflammation of the mucosa Not Applicable

Medical Conditions Aggravated by Exposure Open sores and wounds of the skin. Individuals with known sensitivity to methacrylates, acrylates, or urethane

dimethacrylate resin used in Dental restorative products.

Carcinogenicity NTP?: Not listed IARC monographs?: Not listed OSHA regulated?: No All components of this product are in compliance with the inventory listing Requirements of the U. S. Toxic Substances Control Act (TSCA) Chemical Substance Inventory.

Potential Environmental Effects Do not allow to enter sewers/ surface or ground water.

NFPA Hazard Classification Ratings (Scale 0-4), Health = 1, Fire = 1, Reactivity = 0

12.Ecological Information Toxicity Data, Environmental Fate, Physical/Chemical Data, or other Data Supporting Environmental Hazard Statements: Water Hazard class1 (Self-assessment): slightly hazardous for water. Do not allow undiluted product or large quantities of it to reach ground water, water streams or sewage system.

13.Disposal Considerations Regulations: Must not be disposed of together with household garbage. Do not allow product to reach sewage system.

Dispose of material as solid waste in a closed container. Dispose of in accordance with Federal, State and Local regulations

Properties (Physical/Chemical) Affecting Disposal: Dispose of material as solid waste in a closed container.

14.Transport Information Regulated for Shipping: No. Not Regulated DOT Shipping Name: Not Regulated Packing Group: Not Applicable

Do Changes in Quantities, packaging, or shipment

method change product classification? No

DOT Hazard Class: Not Applicable UN Number: Not Applicable

15.Regulatory Information This product has been classified in accordance with the hazard criteria of the Globally Harmonized System of Classification and

Labeling of Chemicals and the SDS contains all of the information required by the Canadian Controlled Products Regulations. U.S. Federal Regulations: CERCLA 103 Reportable Quantity: This product is not subject to CERCLA reporting requirements. Many states have more stringent release reporting requirements. Report spills required under federal, state and local regulations

Section 313 Toxic Chemicals: This product contains the following chemicals subject to Annual Release Reporting Requirements Under SARA Title III,

Section 313 (40 CFR 372): None

Section 302 Extremely Hazardous Substances (TPQ): None

EPA Toxic Substances Control Act (TSCA) Status: All of the components of this product are listed on the TSCA inventory.

U.S. State Regulations California Proposition 65: This product does not contain any chemicals, which are on the California Proposition 65 list.

International Regulations: Canadian Environmental Protection Act:

This product is a medical device and not subject to chemical notification requirements.

European Community Labeling: Not a dangerous preparation.

European Inventory of New and Existing Chemicals Substances (EINECS):



16.Other Information To the best of our knowledge this product does not contain gluten, wheat grains, flaxseed, natural rubber, or natural latex. All components are synthetically produced; none are derived from animal products.

This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific products features and shall not establish a

legally valid contractual relationship. The attached safety data sheet covers the dangers and measures to be taken when large quantities of material are released, for example due to accidents during

transport or storage by the dealer. For quantities of material typically used in clinical practice, information necessary for safe use and storage of the product is

given in the DFU.


DENTSPLY/Caulk


1. Product and Company Identification Product Name PRIME & BOND

®NT

™ Nano – Technology Dental Adhesive


Trade Name & Synonyms PRIME & BOND

®NT

™ Nano – Technology Dental Adhesive


Manufacturer:

DENTSPLY Caulk

Address 38 West Clarke Avenue


http://www.caulk.com Grades or Minor Variant Identities Unit Dose Package

Information Telephone Number (302) 422-4511 (8:00 AM – 4:30 PM Eastern Time)

Product Use (for Canada) Dental Bonding Agent

Emergency Telephone Number (302) 422-4511 (8:00 AM – 4:30 PM Eastern Time)


Keep away from heat/sparks/open flames / hot surfaces.

No smoking.

Keep container tightly closed.

Wear protective gloves/eye protection/face protection.

Ground / Bond container and receiving equipment.

Use explosion-proof electrical lighting equipment.

Use only non-sparking tools.

Take precautionary measures against static discharge.

IF ON SKIN or Hair: Remove / take off immediately all contaminated

clothing. Rinse skin with water / shower.

In case of fire: Use CO2 sand or extinguishing powder.


Wear protective gloves




3. Composition/Information on Ingredients

Hazardous Components C.A.S. Number Exposure Limits %

Acetone 67-64-1 500 ppm < 70

Urethane dimethacrylate resin 105883-40-7 Not Established < 20

Dipentaerythritol pentaacrylate phosphate 87699-25-0 Not Established < 10

Polymerizable dimethacrylate resins 2358-84-1 Not Established < 10

Polymerizable trimethacrylate resins 3290-92-4 Not Established < 10

4. First Aid Measures

Routes of

Exposure

First Aid Instructions Immediate

Medical Attention

Delayed Effects

Eye Rinse opened eye for several minutes under running water.

If symptoms persist consult physician.



Inhalation Supply fresh air Not Applicable Not Applicable

Ingestion If symptoms persist consult physician Not Applicable Not Applicable

Other Not Applicable Not Applicable Not Applicable


Warning

Highly Flammable Liquid and Vapour

Warning

Causes Skin Irritation

5. Fire and Explosion Data

Flashpoint Method: -19 C (-2 F)

Pensky-Marten Closed Cup

Flammable (Explosive) Limits in Air

LEL: 2.5 vol. % UEL: 12. 8 vol. % Autoignition Temperature: 465 C

(869 F)

Other: Not

Applicable Flame Propagation or Burning Rate

(for Solids): Not Applicable

Properties Contributing to Fire Intensity: Not

Applicable

Flammability Classification: 3

Extinguishing Media: CO2, sand or extinguishing powder. Extinguishing Media to Avoid: Do not use water or water with full jet.

Protection and Procedures for Firefighters: Firefighters should wear self-contained respiratory protective devices. Unusual Fire and Explosion Hazards: Formation of toxic gases is possible during heating or in case of fire.

6. Accidental Release Measures Containment Techniques: Wear protective clothing. Absorb with liquid binding material (sand, vermiculite, diatomite, acid binders, universal binders or sawdust). Scoop up bulk material and place in a labeled plastic or metal container.

Spill/Leak Clean-up Procedures and Equipment: Wear protective clothing. Absorb with liquid binding material (sand, vermiculite, diatomite, acid binders, universal

binders or sawdust). Scoop up bulk material and place in a labeled plastic or metal container. Avoid gross skin contact to minimize the possibility of contact dermatitis to susceptible persons. Ensure adequate ventilation.


7. Handling and Storage Handling Practices and Warnings: Handling of this product should be by trained dental healthcare professionals only. Observe normal care for working with chemicals. Storage Practices and Warnings: Store in a well-ventilated place. Keep cool. Store only in the original package. Keep package tightly sealed. Protect from exposure to

direct light. Store away from food and beverages.


Ventilation: None required during normal intended use of this product Other Engineering Controls: Not Applicable

Routes of Entry Personal Protective Equipment (PPE) for Normal Use PPE for Emergencies


Skin The glove material has to be impermeable and resistant to the product. Not Applicable

Inhalation Not required for normal volumes used in Dental office. Not Applicable


General Hygiene Considerations and Work Practices: Keep away from foodstuffs, beverages and feed. Immediately remove all soiled and contaminated clothing.

Wash hands before breaks and at end of work. Avoid contact with the eyes and skin.

Protective Measures During Repair and Maintenance of Contaminated Equipment: Not Applicable

Other Protective Measures and Equipment: Not Applicable

9. Physical and Chemical Characteristics

Appearance: Light yellow liquid. Odor: Acetone odor.

Normal Physical State: Low viscosity liquid Melting Point: Not Determined Boiling Point: 54.2°C (129.6 F)

Specific Gravity: ~0.9 g/cm3 Solubility in Water: Partially

Vapor Pressure (mm Hg): 233 mbar @ 20 C Vapor Density (AIR=1): Not Applicable Vapor Pressure (mm Hg): 233 mbar @ 20 C


10. Stability and Reactivity Data Incompatibility (Materials to Avoid): Visible light, high temperatures, strong acids, strong oxidizing agents.

Hazardous Products Produced During Decomposition: Methacrylates, acrylates, carbon dioxide, carbon monoxide, peroxides and irritating gases.

Hazardous Polymerization: May Occur May Not Occur Conditions to Avoid: High Temperatures, ignition sources.

Stability? Stable Unstable Conditions to Avoid: High Temperatures, ignition sources.

11. Toxicological Information

Emergency Overview: Material is flammable. Material is irritating to eyes, respiratory system and skin. Toxicity Data, Epidemiology Studies, Carcinogenicity, Neurological Effects, Genetic Effects, Reproductive Effects, or Structure Activity Data:

Product is an irritant to skin and mucous membranes. The unpolymerized product may be an irritant to the skin in susceptible persons. On the eye the product has an irritating effect. Sensitization: Repeated or prolonged contact with the unpolymerized material may cause sensitization for persons allergic to acrylates and

methacrylates. This product shows the following dangers according to internally approved calculation methods for composite materials: Irritant.

Routes of

Exposure

Signs and Symptoms Single, Repeated,

or Lifetime

Exposure

Severity (Mild,

Moderate, Severe)

Acute and Chronic Health Effect(s)

Target

Organ(s) Eye Material can cause irritation. Single Moderate Irritation and possible corneal damage Yes

Skin Material may be an irritant and may be absorbed through the skin.

Single & Repeated Moderate Irritation or possible allergic response. Severe allergic response may result

Yes

in breathing difficulties.

Inhalation Inhalation of high concentrations

may cause central nervous system effects characterized by nausea,

headache, dizziness,

unconsciousness and coma.

Repeated Moderate Chronic inhalation may cause effects similar to

those of acute inhalation. Causes respiratory tract irritation. May cause motor incoordination

and speech abnormalities.

Yes

Ingestion May cause irritation of the digestive

tract.

Single & Repeated Mild Not Applicable No

Other: Central

nervous system

Not Applicable Not Applicable Not Applicable Not Applicable Not Applicable

Medical Conditions Aggravated by Exposure: Open sores and wounds of the skin. Individuals with known sensitivity to

methacrylates, acrylates, or urethane dimethacrylate resin used in Dental restorative products. Carcinogenicity NTP?: Not listed IARC monographs?: Not listed OSHA regulated?: No. All components of this product are in compliance with the

inventory listing Requirements of the U. S. Toxic Substances Control Act (TSCA) Chemical Substance Inventory.


NFPA Hazard Classification Ratings (Scale 0-4) Health = 1, Fire = 3, Reactivity = 0 Specific Hazard = None

12. Ecological Information Toxicity Data, Environmental Fate, Physical/Chemical Data, or other Data Supporting Environmental Hazard Statements: Harmful to fish. Harmful to aquatic organisms.

13. Disposal Considerations Regulations: Must not be disposed of together with household garbage. Do not allow product to reach sewage system. Dispose of material as solid

waste in a closed container. Dispose of in accordance with Federal, State and Local regulations


RCRA P-Series: None Listed, RCRA U-Series CAS#67-64-1: Waste Number U002 (Ignitable Waste)

14. Transport Information

Regulated for Shipping: Yes Proper Shipping Name: Acetone Solution Packing Group: II

Do Changes in Quantities, packaging, or shipment method change

product classification? Yes

Hazard Class: 3 UN Identification Number: 1090


Flammable Liquid

15. Regulatory Information This product has been classified in accordance with the hazard criteria of the Globally Harmonized System of Classification and

Labeling of Chemicals and the SDS contains all of the information required by the Canadian Controlled Products Regulations. U.S. Federal Regulations: CERCLA 103 Reportable Quantity: RQ is 5,000 pounds (2268Kg) for CAS# 67-64-1 Acetone. Report spills required under federal, state and local regulations. Many states have more stringent release reporting requirements.

RCRA U-Series Hazardous Waste Code for CAS# 67-64-1 Acetone: U002

Section 313 Toxic Chemicals: This product does not contain any chemicals subject to Annual Release Reporting Requirements Under SARA Title III, Section 313 (40

CFR 372).




Federal Regulations: The product has been classified and marked in accordance with directives on hazardous materials. Hazard Symbol: Flammable Water Hazard class1 (Self-assessment): slightly hazardous for water. SARA Codes: CAS # 67-64-1 Acute, chronic, flammable.

International Regulations: Hazard Symbol: Flammable XI F Risk Phrases: R11 Highly Flammable, R36/37/38 Irritating to Eyes, respiratory system and skin. R52/53

Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment. R67 Vapors may cause drowsiness and dizziness. Safety Phrases: S9

Keep container in well-ventilated place. S16 Keep away from sources of ignition – No Smoking, S26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice, S28 After contact with skin wash immediately with plenty of water, S61 Avoid release to the environment.

Other: Canada WHMIS for the acetone, classification of B2, D2B. Acetone CAS#67-64-1 is on the Canadian Ingredient Disclosure List.

16. Other Information To the best of our knowledge this product does not contain gluten, wheat grains, flaxseed, natural rubber, or natural latex. All components are synthetically produced; none are derived from animal products.

This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific products features and shall not establish a legally

valid contractual relationship. The attached safety data sheet covers the dangers and measures to be taken when large quantities of material are released, for example due to accidents during

transport or storage by the dealer. For quantities of material typically used in clinical practice, information necessary for safe use and storage of the product is given in

the DFU.


DENTSPLY/Caulk


1. Product and Company Identification Product Name CAULK

® 50% Tooth CONDITIONER LIQUID

CAULK® 34% Tooth CONDITIONER GEL

MSDS Code Number 546899

Trade Name & Synonyms CAULK

® 50% Tooth CONDITIONER LIQUID

CAULK® 34% Tooth CONDITIONER GEL


Manufacturer

DENTSPLY/Caulk

Address



http://www.caulk.com, http://www.dentsply.com


Bottles and Syringes

Information Telephone Number (302) 422-4511 (8:00 AM – 4:30 PM Eastern Time)


Not Applicable

Emergency Telephone Number (302) 422-4511 (8:00 AM – 4:30 PM Eastern Time)


Do not breathe in dust or mist.



If SWALLOWED: Rinse mouth. Do NOT induce vomiting.

IF ON SKIN: Remove immediately all contaminated clothing. Rinse skin with water.

If INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing.

Immediately call a POISON Center or physician.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do so. Continue rinsing.

Store locked up.

Dispose of contents/container in accordance with local regulations.

3. Composition of Ingredients – Tooth Conditioner Liquid

Hazardous Components C.A.S. Number Exposure Limits %

Phosphoric Acid 7664-38-2 1 mg/M3 50

3. Composition of Ingredients – Tooth Conditioner Gel Hazardous Components C.A.S. Number Exposure Limits %

Phosphoric Acid 7664-38-2 1 mg/M3 34

Other Information: Blue colorant is a fluorescent organic dye.

4. First Aid Measures

Routes of

Exposure

First Aid Instructions Immediate Medical

Attention

Delayed Effects

Eye IF IN EYES: Rinse cautiously with water for several minutes. Remove

contact lenses, if present and easy to do. Continue rinsing.



Skin IF ON SKIN: Remove/Take off immediately all contaminated clothing.

Rinse skin with water/shower. Wash contaminated clothing before reuse.



Inhalation IF INHALED: Remove victim to fresh air and keep at a rest position Not Applicable Not Applicable

Danger

Causes severe skin burns and eye damage

comfortable for breathing.

Immediately call a poison center or if symptoms persist, consult physician.

Ingestion IF SWALLOWED: Rinse mouth. Do NOT induce vomiting.



Other Not Applicable Not Applicable Not Applicable


5. Fire and Explosion Data Flashpoint Method: Not Applicable Flammable (Explosive) Limits in Air

LEL: Not Established UEL: Not Established

Autoignition Temperature: Not Applicable Other: Not

Applicable Flame Propagation or Burning Rate

(for Solids): Not Applicable

Properties Contributing to Fire Intensity: Not Applicable Flammability Classification: Not

Applicable

Extinguishing Media: Use extinguishing media suitable for surrounding area. Extinguishing Media to Avoid: Water with full jet. Protection and Procedures for Firefighters: Firefighters should wear self-contained respiratory protective devices. Unusual Fire and Explosion Hazards: Formation of toxic gases is possible during heating or in case of fire.

6. Accidental Release Measures Containment Techniques: For Liquid: Absorb with liquid binding material (sand, vermiculite, diatomite, acid binders, universal binders or sawdust). For Gel, since material is a paste, scoop up bulk material and place in a suitable waste container. Spill/Leak Clean-up Procedures and Equipment: Absorb with liquid binding material (sand, vermiculite, diatomite, acid binders, universal binders or sawdust).

Scoop up bulk material and place in a suitable waste container.



Observe normal care for working with chemicals. Storage Practices and Warnings: Store only in the original package. Keep package tightly sealed. Store in a dry area. Store away from food and beverages.


Ventilation: None required during normal intended use of this product Other Engineering Controls: Not Applicable

Routes of Entry Personal Protective Equipment (PPE) for Normal Use PPE for Emergencies


Skin The glove material has to be impermeable and resistant to the product. Not Applicable

Inhalation Not required for normal volumes used in Dental office. Not Applicable


General Hygiene Considerations and Work Practices: Keep away from foodstuffs, beverages and feed. Immediately remove all soiled and contaminated clothing. Wash hands before breaks and at end of work. Avoid contact with the eyes and skin.

Protective Measures During Repair and Maintenance of Contaminated Equipment: Not Applicable

Other Protective Measures and Equipment: Not Applicable

9. Physical and Chemical Characteristics Appearance: Liquid is clear. Gel is blue colored paste. Odor: Acrid. Normal Physical State: Liquid, Gel is a paste. Melting Point: Not Applicable

Specific Gravity: 1.3 g/cm3 Solubility in Water: Not Soluble pH: < 2

Vapor Pressure (mm Hg): Not Established Vapor Density (AIR=1): Not Applicable Evaporation Rate (Butyl Acetate =1) Not Applicable

10. Stability and Reactivity Data Incompatibility (Materials to Avoid): Not Applicable

Hazardous Products Produced During Decomposition: Not Applicable.

Hazardous Polymerization: May Occur May Not Occur Conditions to Avoid: High Temperatures, ignition sources.

Stability? Stable Unstable Conditions to Avoid: High Temperatures, ignition sources.

11. Toxicological Information

Toxicity Data, Epidemiology Studies, Carcinogenicity, Neurological Effects, Genetic Effects, Reproductive Effects, or Structure Activity Data: Material is a corrosive acid and as such is irritating to skin and mucous membranes.

Emergency Overview: Material is corrosive. Routes of

Exposure

Signs and Symptoms Single, Repeated, or

Lifetime Exposure

Severity (Mild,

Moderate, Severe)

Acute and Chronic Health Effect(s) Target

Organ(s)

Eye Material is corrosive and

may cause irritation.

Single & Repeated Severe Irritation and possible corneal damage due

to the corrosive nature of product.

Not Applicable

Skin Material is corrosive and may cause irritation.

Single & Repeated Moderate to severe depending on

contact time.

Irritation due to the corrosive nature of the product.

Not Applicable


Ingestion Material is corrosive and may cause irritation.

Not Applicable Moderate Irritation due to the corrosive nature of the product.

Not Applicable

Other Not Applicable Not Applicable Not Applicable Not Applicable Not Applicable

Medical Conditions Aggravated by Exposure: Open sores and wounds of the skin.



NFPA Hazard Classification Ratings (Scale 0-4), Health = 3, Fire = 0, Reactivity = 0 Specific Hazard = Corrosive / Acid

12. Ecological Information Toxicity Data, Environmental Fate, Physical/Chemical Data, or other Data Supporting Environmental Hazard Statements: Water Hazard class1 (Self-assessment):

slightly hazardous for water. Do not allow undiluted product or large quantities of it to reach ground water, water streams or sewage system. Toxic to fish. Also poisonous for fish and plankton in water bodies. Toxic for aquatic organisms.

13. Disposal Considerations Regulations: Must not be disposed of together with household garbage. Do not allow product to reach sewage system.



14. Transport Information

Regulated for Shipping: Yes DOT Shipping Name: Corrosive Liquid, n.o.s. (contains Phosphoric Acid) Packing Group: II

Do Changes in Quantities, packaging, or shipment method change product

classification? Yes

Hazard Class: 8 UN Identification Number: 1760

15. Regulatory Information This product has been classified in accordance with the hazard criteria of the Globally Harmonized System of Classification and

Labeling of Chemicals and the SDS contains all of the information required by the Canadian Controlled Products Regulations. U.S. Federal Regulations: CERCLA 103 Reportable Quantity: CAS# 7664-38-2 Phosphoric Acid 5000 pounds (2268Kg) Many states have more stringent release reporting requirements. Report spills required under federal, state and local regulations

Section 313 Toxic Chemicals: This product contains the following chemicals subject to Annual Release Reporting Requirements Under SARA Title III, Section

313 (40 CFR 372): None




Canada WHMIS, Workplace Hazardous Materials Information System: This product is not a controlled product.

International Regulations: Canadian Environmental Protection Act: This product is a medical device and not subject to chemical notification requirements.

European Community Labeling: Not a dangerous preparation. These R and S phrases apply to base and catalyst: R36/38 Irritating to eyes and skin. R51/53 Toxic

to aquatic organisms, may cause long-term effects in the environment. S26 Incase of contact with eyes, rinse immediately with plenty of water and seek medical advice. S28 After contact with skin, wash immediately with plenty of water. S37 Wear suitable gloves. S57 Use appropriate container to avoid environmental

contamination. S60 This material and its container must be disposed of as hazardous waste. These R and S phrases apply to catalyst: R41 Risk of serious damage

to eyes. R50/53 Very toxic to aquatic organisms, may cause long-term effects in the environment. S24 Avoid contact with skin.

European Inventory of New and Existing Chemicals Substances (EINECS): This product is a medical device and not subject to chemical notification

requirements. Phosphoric Acid is known as EINECS #: 231-633-2 and CAS# 7664-38-2.

Other: Not Applicable.

16. Other Information To the best of our knowledge this product does not contain gluten, wheat grains, flaxseed, natural rubber, or natural latex. All components are synthetically produced; none are derived from animal products.

This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific products features and shall not establish a

legally valid contractual relationship. The attached safety data sheet covers the dangers and measures to be taken when large quantities of material are released, for example due to accidents during

transport or storage by the dealer. For quantities of material typically used in clinical practice, information necessary for safe use and storage of the product is

given in the DFU.


DENTSPLY/Caulk


1. Identification Product Name

EsthetX® flow Liquid Micro Hybrid Restorative


Substance Identity

EsthetX® flow Liquid Micro Hybrid Restorative


Manufacturer:

DENTSPLY Caulk

Address



http://www.caulk.com http://www.dentsply.com


Not Applicable

Information Telephone Number



Light Curing Composite/Dental Filling Material Emergency Telephone Number








3. Composition/Information on Ingredients Hazardous Components C.A.S. Number Exposure Limits %

Silica (Amorphous) 67762-90-7 3 mg/m3 < than 5

Barium boron fluoro alumino silicate glass 65997-18-4 10 mg/m3 < than 70

Urethane modified Bis-GMA dimethacrylate 126646-17-1 N.E. < than 10

Bis-GMA 1565-94-2 N.E. < than 20

Polymerizable dimethacrylate resins 24448-20-2/109-16-0 N.E. < than 25

Other Information: Colorants are inorganic iron oxides and titanium dioxide.

4. First Aid Measures Routes of Exposure First Aid Instructions Immediate Medical Attention Delayed Effects

Eye Rinse opened eye for several minutes under running water. If symptoms persist consult physician



Inhalation Not Applicable Not Applicable Not Applicable

Ingestion Not Applicable Not Applicable Not Applicable

Mucosa Rinse tissue for several minutes under running water. If symptoms persist consult physician



5. Fire Fighting Measures Flame Propagation or Burning Rate

(for Solids) Not Applicable

Properties Contributing to Fire Intensity Not Applicable

Flammability Classification: Not Applicable Other: Not Applicable

Extinguishing Media: CO2, extinguishing powder, foam carbon dioxide or water

spray. Fight larger fires with water spray or alcohol resistant foam. Extinguishing Media to Avoid: Water with full jet.

Protection and Procedures for Firefighters: Firefighters should wear self-contained respiratory protective devices. Unusual Fire and Explosion Hazards: Formation of toxic, irritating gases is possible from the decomposition of the dimethacrylate resins. Product does not present an explosion hazard.

6. Accidental Release Measures

WARNING

CAUSES SKIN IRRITATION

Containment Techniques: Material is a paste and as such will not flow. Spill/Leak Clean-up Procedures and Equipment: Wear protective clothing and scoop up bulk material and place in a labeled plastic or metal container.

Avoid gross skin contact to minimize the possibility of contact dermatitis to susceptible persons. Ensure adequate ventilation.



Observe normal care for working with chemicals. Storage Practices and Warnings: Store only in the original package. Keep package tightly sealed. Store in a dry area. Protect from exposure to direct light. Store away from food and beverages.


Occupational Exposure Limits: Not Applicable

Engineering Controls: Not Applicable

Individual Protection

Measures Personal Protective Equipment for Normal Use Personal Protective Equipment for Emergencies


Skin The glove material has to be impermeable and

resistant to the product.

Not Applicable

Inhalation Not Required Not Applicable


9. Physical and Chemical Characteristics Appearance: Various shades of viscous paste. Odor: Characteristic sweet acrylic ester odor. Normal Physical State: Very High Viscosity Liquid (Paste) Melting Point: Not Applicable

Specific Gravity: 1.8 g/cm3 Solubility in Water: Not soluble pH: Not Applicable

Vapor Pressure (mm Hg): Not Applicable Vapor Density (AIR=1): Not Applicable Evaporation Rate (Butyl Acetate =1): Not Applicable

Flashpoint Method: Not Applicable Flammable (Explosive) Limits in Air LEL: Not Applicable UEL: Not Applicable

Autoignition Temperature: Not Applicable, Product will not autoignite.


10. Stability and Reactivity Data Incompatibility (Materials to Avoid): Strong Oxidizing materials.

Hazardous Products Produced During Decomposition: No dangerous decomposition products known if used according to Directions for Use.

Hazardous Polymerization: May Occur May Not Occur Conditions to Avoid: None known

Stability? Stable Unstable Conditions to Avoid: None known

11.Toxicological Information Toxicity Data, Epidemiology Studies, Carcinogenicity, Neurological Effects, Genetic Effects, Reproductive Effects, or Structure Activity Data:

Product is an irritant to the skin and mucous membranes. The unpolymerized product may be an irritant to the skin in susceptible persons. On the eye the product has an irritating effect. Sensitization: Repeated or prolonged contact with the unpolymerized material may cause sensitization for persons allergic to

acrylates and methacrylates. This product shows the following dangers according to internally approved calculation methods for composite materials: Irritant.

Emergency Overview Material is irritating to eyes, respiratory system and skin.

Routes of Exposure

Signs and Symptoms

Single, Repeated, or Lifetime Exposure

Severity (Mild, Moderate, Severe)

Acute and Chronic Health Effect(s) Target Organ(s)

Eye Material can cause

irritation.

Single Moderate Irritation and possible corneal damage Not Applicable

Skin Material may be an irritant

Single & Repeated Moderate Irritation or possible allergic response. Severe allergic response may result in

breathing difficulties.

Not Applicable


Ingestion Material is not harmful if swallowed using clinically

relevant quantities

Not Applicable Mild Not Applicable Not Applicable

Mucosa Material can cause irritation.

Single Mild Inflammation of the mucosa Not Applicable

Medical Conditions Aggravated by Exposure Open sores and wounds of the skin. Individuals with known sensitivity to methacrylates, acrylates, or urethane

dimethacrylate resin used in Dental restorative products.



NFPA Hazard Classification Ratings (Scale 0-4), Health = 1, Fire = 0, Reactivity = 0

12.Ecological Information Toxicity Data, Environmental Fate, Physical/Chemical Data, or other Data Supporting Environmental Hazard Statements: Water Hazard class1 (Self-

assessment): slightly hazardous for water. Do not allow undiluted product or large quantities of it to reach ground water, water streams or sewage system.

13.Disposal Considerations Regulations: Must not be disposed of together with household garbage. Do not allow product to reach sewage system.



14.Transport Information Regulated for Shipping: No. Not Regulated DOT Shipping Name: Not Regulated Packing Group: Not Applicable

Do Changes in Quantities, packaging, or shipment

method change product classification? No

DOT Hazard Class: Not Applicable UN Number: Not Applicable

15.Regulatory Information This product has been classified in accordance with the hazard criteria of the Globally Harmonized System of Classification and

Labeling of Chemicals and the SDS contains all of the information required by the Canadian Controlled Products Regulations. U.S. Federal Regulations: CERCLA 103 Reportable Quantity: This product is not subject to CERCLA reporting requirements. Many states have more

stringent release reporting requirements. Report spills required under federal, state and local regulations

Section 313 Toxic Chemicals: This product contains the following chemicals subject to Annual Release Reporting Requirements Under SARA Title III,

Section 313 (40 CFR 372): None




International Regulations: Canadian Environmental Protection Act:


European Community Labeling: Not a dangerous preparation.

European Inventory of New and Existing Chemicals Substances (EINECS): This product is a medical device and not subject to chemical notification requirements.


16.Other Information To the best of our knowledge this product does not contain gluten, wheat grains, flaxseed, natural rubber, or natural latex.

All components are synthetically produced; none are derived from animal products. This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific products features and shall not establish a

legally valid contractual relationship.

The attached safety data sheet covers the dangers and measures to be taken when large quantities of material are released, for example due to accidents during transport or storage by the dealer. For quantities of material typically used in clinical practice, information necessary for safe use and storage of the product is

given in the DFU.

Documents

DENTSPLY/International DENTSPLY/Caulk Safety Data Sheet …€¦ · Safety Data Sheet 530699 1. Identification Product Name Esthet•X® HD SDS Code Number 530699 Substance Identity